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NCT Number: NCT07656454

A Study Understanding How Much CDR132L Enters the Bloodstream After Injection Under the Skin Compared to Injection Into a Vein in Healthy Participants

This study is being done to understand how much of the medicine (CDR132L) enters the bloodstream after injection under the skin compared to injection into a vein in healthy people. This will help us find the best way to give the medicine to people living with heart failure. The study will assess what the body does to the medicine, and how safe it is.

Recruiting

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel International GmbH

Berlin, 14050, Germany

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female (sex at birth).
  • Age 18-55 years (both inclusive) at the time of signing the informed consent.
  • Body mass index 18.5-29.9 kilograms per square metre (kg/m^2) (both inclusive) and body weight less than or equal to (≤) 120 kilograms (kg) at screening (visit 1).
  • Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit (visit 1), as judged by the investigator.

Exclusion criteria

  • Any laboratory safety parameters at screening (visit 1) outside the below laboratory ranges, see laboratory manual for specific values.
  • Alanine aminotransferase (ALT) greater than (>) upper limit of normal (ULN) +10 percentage (%)
  • Aspartate aminotransferase (AST) >ULN +20%
  • Bilirubin >ULN +20%
  • Creatinine >ULN +10%
  • Estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) less than (<) 90 milliliters per minute/1.73square meter (mL/min/1.73m^2)
  • Urine albumin-to-creatinine ratio (UACR) greater than or equal to (≥) 30 milligrams per gram (mg/g)
  • Second or third degree atrioventricular-block, prolongation of the QRS complex over 120 milliseconds (ms), or of the QT interval corrected using Fridericia's formula (QTcF) interval over 450 ms, or any other clinically significant abnormal electrocardiogram results as judged by the investigator at screening (visit 1).
  • Supine blood pressure at screening (visit 1) outside the range of 90-139 millimeters of mercury (mmHg) for systolic or 50-89 mmHg for diastolic.
  • Heart rate outside the range of 50-89 beats/minute at screening (visit 1).
  • Presence or history (as declared by the participant or reported in the medical records) of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemia, stroke, heart failure, cardiac decompensation, clinically significant arrhythmia and clinically significant conduction disorders.
  • Known history of severe symptomatic untreated anaemia in the 90 days prior to screening (visit 1) (e.g., haemoglobin <90 grams per litre (g/L))
  • Presence or history (as declared by the participant or reported in the medical records) of acute or chronic kidney disease or injury.
  • Presence of thrombocytopenia, defined as thrombocyte count <150 x 10^9 cells/L at screening (visit 1), or history (as declared by the participant or reported in the medical records) of bleeding disorder.
  • Presence or history (as declared by the participant or reported in the medical records) of conditions associated with disruption of blood-brain barrier (e.g. multiple sclerosis).

Treatment and study plan

CDR132L (i.v.)

Drug

CDR132L will be administered intravenously.

CDR132L (s.c.)

Drug

CDR132L will be administered subcutaneously.

Primary outcomes

  1. Area under the CDR132L plasma concentration-time curve (AUC 0-tz) from 0 hours to tz after a single dose, where tz is the time of last quantifiable concentration

    Time frame: From 0 to 840 hours after CDR132L administration

    Measured as hours*nanograms per milliliter (h*ng/mL)

Secondary outcomes

  1. Area under the CDR132L plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose

    Time frame: From 0 to 840 hours after CDR132L administration

    Measured as h*ng/mL

  2. Maximum observed CDR132L plasma concentration after a single dose

    Time frame: From 0 to 840 hours after CDR132L administration

    Measured as nanograms per milliliter (ng/mL)

  3. Time to maximum observed CDR132L plasma concentration after a single dose

    Time frame: From 0 to 840 hours after CDR132L administration

    Measured in hours

  4. Terminal half-life for CDR132L after a single dose

    Time frame: From 0 to 840 hours after CDR132L administration

    Measured in hours

  5. Area under the CDR132L plasma concentration-time curve from 0 hours to tz after a single dose, where tz is the time of last quantifiable concentration, divided by dose

    Time frame: From 0 to 840 hours after CDR132L administration

    Measured as hours*nanograms per milliliter per milligram (h*ng/mL/mg)

  6. Maximum observed CDR132L plasma concentration after a single dose divided by dose

    Time frame: From 0 to 840 hours after CDR132L administration

    Measured as nanograms per milliliter per milligram (ng/mL/mg)

  7. Total plasma clearance of CDR132L after a single dose

    Time frame: From 0 to 840 hours after CDR132L administration

    Measured as liters per hour

  8. Apparent volume of distribution of CDR132L after a single dose based on plasma concentration values

    Time frame: From 0 to 840 hours after CDR132L administration

    Measured in liters

  9. Mean residence time for CDR132L after a single dose

    Time frame: From 0 to 840 hours after CDR132L administration

    Measured in hours

  10. Number of adverse events

    Time frame: From first CDR132L administration (day 1) to day 141

    Measured as number of events

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Bioavailability Study Comparing the Pharmacokinetics of CDR132L Following Subcutaneous and Intravenous Administration in Healthy Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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